Alkermes plc ALKS announced the initiation of a new phase III study of pipeline candidate ALKS 8700. ALKS 8700 is a monomethyl fumarate (MMF) prodrug which is being developed for the treatment of multiple sclerosis. The trial is a randomized five week, head-to-head phase III study which will evaluate the gastrointestinal tolerability (GI) of ALKS 8700 462 mg twice daily compared to Biogen Inc.’s BIIB Tecfidera 240 mg twice daily in approximately 420 patients with relapsing-remitting MS (RRMS).
Alkermes’ share price has increased 7% year to date, while the Zacks classified Medical - Biomedical and Genetics industry gained 9.8%.
This elective study is part of the ongoing clinical development program for ALKS 8700, named EVOLVE-MS. The data from this study will help in finding ALKS 8700’s potential advantages for patients and its future positioning in the fumarate market, which represents a $3 billion opportunity in the U.S.
Alkermes intends to submit a New Drug Application (NDA) for ALKS 8700 for the treatment of RRMS to the FDA in 2018.
Alkermes’ key areas of focus include central nervous system (CNS) disorders like schizophrenia, depression, addiction and multiple sclerosis. In fact, one of its drugs Ampyra/Fampyra, which is marketed in the U.S. by Acorda Therapeutics, Inc. ACOR, helps in improving walking ability in multiple sclerosis patients. The drug reported sales of $87.2 million in 2016, down 13.4% year over year. Thus, an approval by the FDA for ALKS 8700 would boost the sales of Alkermes for the treatment of multiple sclerosis.
Alkermes PLC Price
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Zacks Rank & Stocks to Consider
Alkermes currently has a Zacks Rank #3 (Hold). Another better-ranked stocks in the health care sector include includes Heska Corp. HSKA, which carries a Zacks Rank #1 (Strong Buy), Addus HomeCare carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Heska’s earnings estimates increased from $1.53 to $1.65 for 2017 and from $1.90 to $2.01 for 2018, over the last 30 days. The company posted a positive earnings surprise in all of the four trailing quarters with an average beat of 291.54%. Its share price increased 34.2% year to date.
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